Credentials that matter
Skills and tools
- cGMP
- 21 CFR 210/211
- ICH Guidance
- Radiopharmaceutical
- Alcoa+
- 21 CFR Part 11
Required qualifications
Bachelor's degree in life sciences, engineering, or related field (or equivalent experience); 8+ years in regulated production (ISO 9001, cGMP pharmaceutical/radiopharmaceutical); 3+ years QA experience; strong knowledge of FDA/cGMP (21 CFR 210/211) and ICH Guidance; proven ability to interpret federal regulations and manage complex projects; excellent written/verbal communication and cross-functional leadership skills.
About this role
TerraPower Isotopes seeks an experienced Senior Quality Assurance Specialist to lead quality assurance and regulatory compliance for Ac-225 radiopharmaceutical production at the Everett, WA manufacturing facility. Responsibilities include cGMP compliance, quality system design, batch disposition, deviation/CAPA management, supplier audits, and FDA/ICH regulatory adherence for advanced isotope manufacturing.
Responsibilities
- Lead quality-driven project teams and optimize site policies/procedures to support cGMP implementation
- Review and disposition batch records, Certificates of Analysis, and supporting documentation; approve quality deviations, change controls, CAPA, and complaints
- Provide QA support for routine production activities and lead internal, supplier, and customer audits with timely resolution of findings
- Support supplier qualification program, Quality Management System implementation, and equipment/facility/process validation and qualification
- Ensure data integrity compliance (ALCOA+, 21 CFR Part 11); balance quality, compliance, and radiation safety requirements
- Deliver quality training and serve as subject-matter expert; promote quality culture across the organization
Preferred qualifications
Certification in pharmaceutical Quality discipline; Lean Six Sigma or project management certification; production radiopharmaceutical facility experience.
Location, schedule, and travel
Everett, WA; occasional evening or weekend work may be required to support production operations or project deliverables.
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